Research biobanks: Questions and regulations

Biobanks, in the long run, are assuming a very important role in the field of scientific research. In fact, the advancement of scientific knowledge is considerably facilitated by the opportunity for the researchers to resort to extensive collections of high quality biological samples. However, in this area, the scientific freedom and interests must be balanced with the necessary protection of the human being. From a legal point of view, however, it should be pointed out that the growing importance of research biobanks and the delicacy of the issues raised by them do not appear to be adequately addressed by the legislator since there is no legal framework on such specific matter. In the expectation of a thorough intervention by the legislator, the present study intends to highlight the specific and entirely peculiar issues raised by research biobanks and the current regulations. In particular, attention is focused on the most delicate issues, such as those relating to the legal nature, the ownership and the circulatory events of biological samples, the informed consent of their donors and the treatment of sensitive and genetic data.